BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 5034257 · Received August 27, 2015

    Report

    Report Number
    2520274-2015-15493
    Event Type
    Injury
    Date Received
    August 27, 2015
    Report Date
    August 16, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. GAVASKAR,ASHOK S., MS ORTHO, TUMMALA, NAVEEN C., ¿LOCKED PLATE OSTEOSYNTHESIS OF HUMERAL HEAD-SPLITTING FRACTURES IN YOUNG ADULTS¿,J SHOULDER ELBOW SURG(2015),908-914. THIS REPORT IS FOR AN UNKNOWN PROXIMAL HUMERUS INTERLOCKING SYSTEM (PHILOS). ADDITIONAL COMMON DEVICE NAME AND DEVICE PRODUCT CODE: SCREW,FIXATION,BONE ¿ HWC. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE. GAVASKAR, ASHOK S., MS ORTHO, TUMMALA, NAVEEN C., MS ORTHO, "LOCKED PLATE OSTEOSYNTHESIS OF HUMERAL HEAD-SPLITTING FRACTURES IN YOUNG ADULTS" JOURNAL OF SHOULDER AND ELBOW SURGERY (2015) 24,908-914. THIS WAS A RETROSPECTIVE SINGLE-CENTER STUDY. THE MEDICAL RECORDS OF ADULT PATIENTS TREATED FOR A HEAD-SPLITTING PROXIMAL HUMERUS FRACTURE FROM JANUARY 2008 TO DECEMBER 2010 WERE RETRIEVED. PATIENTS YOUNGER THAN 55 YEARS PRESENTING WITH A HUMERAL HEAD-SPLITTING FRACTURE WERE INCLUDED. RECORDS OF 16 PATIENTS <55 YEARS WHO UNDERWENT LOCKED PLATING FOR HUMERAL HEAD-SPLITTING FRACTURES WERE REVIEWED. FIVE FRACTURES WERE CLASSIFIED AS SIMPLE (ISOLATED HEAD-SPLITTING FRACTURES) AND 11 AS COMPLEX FRACTURES (ASSOCIATED TUBEROSITY FRACTURES). UNION AND QUALITY OF ARTICULAR AND TUBEROSITY REDUCTION WERE ASSESSED RADIOLOGICALLY. OSTEOSYNTHESIS WITH A PRECONTOURED FIXED ANGLE PLATE WAS PERFORMED IN ALL PATIENTS. AFTER REDUCTION AND PRELIMINARY FIXATION WITH K-WIRES, ANGLE STABLE FIXATION WAS PERFORMED WITH THE PROXIMAL HUMERUS INTERLOCKING SYSTEM (PHILOS; SYNTHES MEDICAL PVT LTD., GURGAON, HARYANA, INDIA). A MINIMUM OF 7 SCREWS WERE USED TO FIX THE PROXIMAL PORTION OF THE PLATE, INCLUDING AT LEAST 1 OF THE 2 INFEROMEDIAL CALCAR SCREWS. THERE WERE 11 MEN AND 5 WOMEN. THE MEAN AGE WAS 38 YEARS (21-54 YEARS). THE MODE OF VIOLENCE WAS A HIGH VELOCITY ROAD TRAFFIC ACCIDENT IN 13 PATIENTS, A FALL FROM A HEIGHT IN 2 PATIENTS, AND AN INDUSTRIAL ACCIDENT IN 1 PATIENT. THE FRACTURE PATTERN WAS SIMPLE IN 6 PATIENTS AND COMPLEX IN 10 PATIENTS. THE MEAN TIME FROM INJURY TO SURGERY WAS 4 DAYS (1-13 DAYS). THE MEAN FOLLOW-UP WAS 34 MONTHS (25-47 MONTHS). THE FINAL ANALYSIS INCLUDED 15 PATIENTS, INCLUDING 1 PATIENT WHO DROPPED OUT AFTER DIAGNOSIS OF A NONUNION AND SECONDARY ARTHRITIS AT 8 MONTHS; 1 PATIENT WITH A SIMPLE FRACTURE COULD NOT BE LOCATED FOR FOLLOW-UP ASSESSMENT. NO OSTEONECROSIS OR NONUNION WAS SEEN IN SIMPLE FRACTURES. IN COMPLEX FRACTURES, OSTEONECROSIS AVASCULAR NECROSIS (AVN) WAS SEEN IN 4 PATIENTS, 2 PATIENTS WITH AVN ALSO HAD AN ANTERIOR DISLOCATION. NONUNION IN 2 PATIENTS, AND GLENOHUMERAL ARTHRITIS IN 1 PATIENT. THE HEAD-SHAFT ANGLE WAS CLASSIFIED AS NORMAL IN 13 PATIENTS, VALGUS IN 1 PATIENT, AND VARUS IN 1 PATIENT. TUBEROSITY FRACTURES WERE REDUCED SATISFACTORILY IN 9 OF 10 PATIENTS. VARUS COLLAPSE WAS SEEN IN 2 PATIENTS. PRIMARY INTRA-ARTICULAR SCREW PLACEMENT WAS SEEN IN 1 PATIENT AND WAS REVISED POSTOPERATIVELY. SECONDARY ARTICULAR SCREW PENETRATION WAS EVIDENT IN 2 PATIENTS AFTER AVN AND SECONDARY COLLAPSE. ONE PATIENT UNDERWENT ACROMIOPLASTY AND SUBACROMIAL DECOMPRESSION FOR SYMPTOMATIC IMPINGEMENT. COMPLICATIONS SUCH AS AVN AND NONUNION NECESSITATING FURTHER TREATMENT WERE SEEN IN 5 OF 10 PATIENTS WITH COMPLEX FRACTURES. THIS REPORT IS 2 OF 8 FOR (B)(4). AN UNKNOWN PROXIMAL HUMERUS INTERLOCKING SYSTEM (PHILOS), FOR PATIENT # (B)(6), A (B)(6) FEMALE WHO EXPERIENCED SECONDARY INTRA-ARTICULAR (IA) SCREW PENETRATION WHICH WAS EVIDENT AFTER AVASCULAR NECROSIS (AVN) AND SECONDARY COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569433 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention